Discussions continued around Drug Listing of Export Products. There is still some uncertainty on how to procede. Currently, many companies are not listing products intended for export only. However, controlled substances need an NDC number to be registered with the DEA. If the products are solely used for the purposes of export, then these products are drug listed assigned an NDC code which is passed to the DEA. Under the current process, the product is drug listed with its appropriate labeling (usually in foreign language). This poses many issues moving forward if the product is listed in SPL r.4. Will this product go to DailyMed?How will labeling accompany the product if only a foreign language is available. One concern about submitting foreign language labeling in the SPL would be that it would be posted to DailyMed and consumers may use their native language to read labeling that is not approved within the U.S. Is there a possibility there may be another type of SPL file that may be submitted for export only products?
The workgroup found that additional operational detail surrounding "exports only" products may be needed. Additionally, the LOINC code for export only products will be needed.
2. Regulation Interpretation Differs:
Organizations are interpreting the regulations differently and are looking for guidance from FDA to their current thinking. This may be mostly addressed by the guidance document once it is released, but there are visible differences in interpretations such as the drug listing of export only products. There are sites such as the Annex B of the drug listing instructions (http://www.fda.gov/cder/drls/default.htm) which give instructions on drug listing export only products, but does not seem to have any basis within the regulations or the FD&C Act. Perhaps an update of this website can help address some of the confusion.
3. DUNS numbers and Third Parties:
Many companies have started retrieving DUNS numbers from their third party manufacturers. There has been some push back by third party manufacturers in readily supplying this information. If the DUNS number is not supplied to FDA and an FEI number is used instead, how will FDA gather this information on the third party? Is there a way to ensure that the numbers are in synchronicity if the third party eventually provides a number?
4. Process Question Log
We are keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log. This is a forum for which team members can actively seek answers to questions circulating about anything related to SPL r.4, so the more questions we have, the more FAQs we will have.
5. Next meeting - March 4, 2009 at 1 PM Eastern Time.
Discussions continued around Drug Listing of Export Products. There is still some uncertainty on how to procede. Currently, many companies are not listing products intended for export only. However, controlled substances need an NDC number to be registered with the DEA. If the products are solely used for the purposes of export, then these products are drug listed assigned an NDC code which is passed to the DEA. Under the current process, the product is drug listed with its appropriate labeling (usually in foreign language). This poses many issues moving forward if the product is listed in SPL r.4. Will this product go to DailyMed? How will labeling accompany the product if only a foreign language is available. One concern about submitting foreign language labeling in the SPL would be that it would be posted to DailyMed and consumers may use their native language to read labeling that is not approved within the U.S. Is there a possibility there may be another type of SPL file that may be submitted for export only products?
The workgroup found that additional operational detail surrounding "exports only" products may be needed. Additionally, the LOINC code for export only products will be needed.
2. Regulation Interpretation Differs:
Organizations are interpreting the regulations differently and are looking for guidance from FDA to their current thinking. This may be mostly addressed by the guidance document once it is released, but there are visible differences in interpretations such as the drug listing of export only products. There are sites such as the Annex B of the drug listing instructions (http://www.fda.gov/cder/drls/default.htm) which give instructions on drug listing export only products, but does not seem to have any basis within the regulations or the FD&C Act. Perhaps an update of this website can help address some of the confusion.
3. DUNS numbers and Third Parties:
Many companies have started retrieving DUNS numbers from their third party manufacturers. There has been some push back by third party manufacturers in readily supplying this information. If the DUNS number is not supplied to FDA and an FEI number is used instead, how will FDA gather this information on the third party? Is there a way to ensure that the numbers are in synchronicity if the third party eventually provides a number?
4. Process Question Log
We are keeping a tracking log of questions related to processes so that we can bring up issues that we are faced to FDA. This list will be maintained on the WIKI so everyone can have access to it. All participants are encouraged to provide input into the question log. This is a forum for which team members can actively seek answers to questions circulating about anything related to SPL r.4, so the more questions we have, the more FAQs we will have.
5. Next meeting - March 4, 2009 at 1 PM Eastern Time.